Biologics

Neurodevelopmental Safety Studies in Neonatal Products

FDA has published a guidance, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development, with a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful to support a determination of the safety of a drug, biological product, or medical device for use in neonates, and which domains of neurodevelopment may be most applicable. The document does not specifically address effectiveness, safety, or benefit/risk assessments for products primarily intended to improve neurologic outcomes, such as neuroprotective agents, FDA says.

Rather, it says, the guidance is focused on long-term evaluations of neurodevelopmental safety. It does not focus on nonclinical safety studies to support clinical studies in neonates, and does not address clinical study design in neonatology. It also does not address neonatal or pediatric safety assessments following studies conducted during pregnancy, nor gene therapies or similar genomic medicine interventions.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome